Medical tube clearance

ABSTRACT

A device for clearing obstructions from a medical tube, such as a chest tube, is disclosed in various embodiments. In embodiments, the device features a clearance member that is formed to match a cross-section of a medical tube. Still further, the clearance member can have a plurality of branches, each branch configured to clear a respective lumen in a partitioned region of a medical tube. In this manner, the clearance member may clear obstructions from individual lumens of the partitioned region of the medical tube. Device for actuating a clearance member to clear obstructions within a medical tube are also disclosed. Methods of clearing a medical tube of obstructions are also disclosed.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. patent application Ser. No.14/624,328 filed Feb. 17, 2015, which claims benefit of U.S. provisionalpatent application Ser. No. 61/940,725 filed Feb. 17, 2014, the contentof which is incorporated herein by reference.

BACKGROUND Field of the Invention

The invention relates to methods and devices to clear obstructive debrisfrom medical tubes. More particularly, it relates to such a devicehaving a clearance member that is formed to match a cross-section of amedical tube or to clear debris from multiple lumens in a medical tube.

Description of Related Art

Millions of medical tubes are used every year to drain bodily fluids andsecretions from within body compartments and structures. For example,such tubes can be used to drain fluid from one's bladder, from the colonor other portions of the alimentary tract, or from the lungs or otherorgans in conjunction with various therapies. Medical tubes also areused to drain blood and other fluids that typically accumulate withinthe body cavity following traumatic surgery. In all these cases, a tubeis inserted into the patient so that its terminal end is provided in oradjacent the space where it is desired to remove accumulated or pooledfluid and the proximal end remains outside the patient's body, where itis typically connected to a suction source.

One of the biggest categories of patients requiring medical tubedrainage is patients who have had heart and lung surgery, nearly all ofwhom require at least one chest tube to drain the space around the heartand lungs after surgery. Chest tubes are long, usually semi-stiff,plastic tubes that are inserted into the chest in the vicinity of theheart and lungs to drain collections of fluids or air from within thepleura, the mediastinum or pericardial space, or from within thethoracic cavity generally.

Fluid and other material accumulating in the vicinity of the medicaltube's distal end (within the patient) is drawn through that tube andout of the space where it accumulated via suction applied at the tube'sproximal end. Ideally, the medical tube will remain free from clots andother debris that may partially or totally obstruct the suction pathwaywithin the medical tube. Unfortunately, however, bodily secretions(particularly those including blood or blood platelets) often form clotswithin medical tubes, which can partially or totally obstruct thesuction pathway within the tube.

Obstruction of a medical tube can impact its effectiveness to remove thefluid and other material for which it was originally placed, eventuallyrendering the medical tube partially or totally non-functional. In somecases, a non-functional tube can have serious or potentiallylife-threatening consequences. For example, if there is a blockage in achest tube following cardiac or pulmonary surgery, the resultingaccumulation of fluid around the heart and lungs without adequatedrainage can cause serious adverse events such as pericardial tamponadeand pneumothorax. In addition to chest tubes used in heart, lung, andtrauma surgery, other medical tubes are prone to clogging as well,including feeding tubes, surgical wound drains, urinary catheters,cardiovascular catheters, and others.

There are few effective techniques to manage medical tube clogging whenit occurs. During the perioperative period following chest surgery ortrauma, clinicians will undertake measures to try to remove any debris(such as a clot) that has accumulated or formed within the chest tube,to keep the tube clear. One method is to simply tap the tube to try andbreak up the debris. Another method is referred to as “milking thetube.” “Milking” involves using one's fingers, or a rudimentary devicecomposed of a pair of pliers with rollers fashioned onto its jaws, tocompress the tube over the debris to try and break it up. The goal is toloosen the debris, or to break it into smaller pieces, so it can be morereadily drawn out of the tube via suction applied at the proximal end.

Another technique is fan folding. In this technique, the clinician bendsthe chest tube in various ways to try to break up any long clots orother obstructions that extend along the axis of the medical tube. Theaim is to produce several smaller pieces of debris, as opposed to onelong piece, that will be more readily drawn proximally via the suctionapplied at the tube's proximal end. Still another technique is known as“stripping.” Here, the clinician takes two fingers lubricated in somefashion, or the improvised device composed of a pair of pliers withrollers mentioned above, and “strips” the tube. This is achieved bycompressing the tube initially near where it enters the patient, anddrawing the compressing apparatus (one's fingers or other compressiondevice) proximally, with compression still applied, along the tube'slength toward the suction source. This is done repeatedly to try andwork any obstructive debris out from the tube and toward the suctionsource.

None of the above techniques is particularly effective. Moreover, theyare time consuming and can be quite painful if the patient is awake andalert when they are performed, due to tugging on the medical tube.Tugging on chest tubes whose terminal ends have been placed near thepleura or pericardium can be especially painful. In addition, the“stripping” technique is known to generate short bursts of extremenegative pressure within chest tubes, which in turn draws a strongsuction in the body cavity where its terminal end has been placed. Thiscan be quite dangerous in certain circumstances. For example, negativepressures of magnitude greater than −300 cm of water can be generatedadjacent suture lines on coronary anastomosis, etc., which can disruptsome of the work that was done during a prior surgery. As a result, manysurgeons have banned stripping their patients' chest tubes due to thepotential for complications.

When the above techniques fail to clear a potentially dangerous clotwithin the tube, a more invasive technique must be used. This requiresestablishment of a sterile field around the chest tube, which isdisconnected from the suction source to manually insert a suctioncatheter to clear the debris. This is known as open chest tubesuctioning, and it can be effective to clear a clogged chest tube. Butit is highly undesirable for a number of reasons. First, it compromisesthe sterile field within the chest tube system by exposing the internalenvironment within that system to the external environment, potentiallyintroducing bacteria inside the chest. Second, the closed system(suction source to chest tube to body space within the chest) typicallymust be breached to insert the catheter inside the chest tube. Breakingthe seal on this system causes loss of the normal physiologic negativepressure inside the chest. This can result in lung collapse(pneumothorax) while suctioning the chest tube. Additionally, thesuction catheter can easily be passed beyond the end of the chest tube,which has the potential to injure the heart or lungs, which could belife threatening. Finally, this procedure is time consuming and usuallycan only be performed by physicians due to the associated dangers. Thusit is only occasionally done in extreme situations when a clogged chesttube is causing a serious acute problem.

Medical tubes may vary in cross-section along their lengths. Forexample, a medical tube may include a single lumen near its proximal endand be partitioned into a plurality of lumens or channels at or towardthe distal end. Additionally, a medical tube may have one or moreopenings and/or apertures that extend through the medical tube's outerwall to allow fluid to be drawn into the medical tube from its side. Oneexample tube is partitioned at is distal end, where a plurality ofopenings at the distal end of the medical tube provide communicationbetween one or more of the partitioned lumens and the space outside themedical tube inside the patient. To assist the suction typically appliedto the medical tube by a vacuum source, such partitioned medical tubesmay help drain fluid from the patient through capillary action via saidopenings. Partitioned medical tubes present a challenge for clearingobstructions from within the partitioned portion of the medical tubebecause a clearance apparatus may not be able to sufficiently clear eachlumen of the medical tube or its partitioned portion. When a clearanceapparatus is inserted into the medical tube from its proximal end, theclearance apparatus may not be able to navigate into each separatelumen, which can result in a clot or occluding material remaining in oneor more of the lumens, thus decreasing the drainage capacity of themedical tube.

Currently, surgeons often implant two or more medical tubes, or employlarge-diameter tubes, following surgery to provide additional drainagecapacity and avoid potentially life-threatening complications of aclogged tube. Methods and apparatus are desirable to keep medical tubes(partitioned or non-partitioned) from clogging or to clear them reliablywithout having to breach the closed system between the suction sourceand the body cavity requiring drainage. Such methods/apparatus may allowsurgeons to place fewer tubes post-surgery, or to select tubes havingsmaller diameters, both of which will reduce patient discomfort andrecovery time. Placement of fewer tubes also will minimize the risk ofinfection.

SUMMARY

A device for clearing obstructions from a medical tube is provided. Thedevice includes an elongate guide member and a clearance member attachedto or formed integrally with the guide member. The clearance member is abranched clearance member having a plurality of individual branches eachconfigured to be received within a respective lumen within the medicaltube.

A further device for clearing obstructions from a partitioned region ofa medical tube is provided. The device includes an elongate guide memberand a clearance member attached to or formed integrally with the guidemember, wherein the clearance member is formed to substantially match across-sectional perimeter shape of a lumen or lumens in the partitionedregion of the medical tube.

An apparatus for clearing obstructions from a medical tube is alsoprovided. The apparatus includes a medical tube coupled to a handleassembly and an elongate guide member extending at least partiallywithin the medical tube, wherein at least a portion of the medical tubeis composed of a flexible material adapted to stretch as the handleassembly is drawn proximally away from a fixed point along a length ofthe medical tube.

A further device for clearing obstructions from a medical tube is alsoprovided. The device includes an adjustable-length guide tube connectedin fluid communication with a medical tube and cooperating therewith toat least partially define a pathway through which obstructions can beevacuated from the medical tube. An elongate guide member extendsthrough the adjustable-length guide tube and the medical tube. Extensionof the adjustable-length guide tube results in withdrawal of the guidemember relative to the medical tube, and collapse (i.e. contraction) ofthe adjustable-length guide tube results in advancement of the guidemember relative to the medical tube.

A method of clearing obstructions from individual distinct lumens in apartitioned region of a medical tube is also provided. The methodincludes the following steps: translating an elongate guide member thatis at least partially disposed within the medical tube, therebycorrespondingly translating a clearance member attached to or formedwith the guide member through the medical tube, wherein the clearancemember includes a plurality of branches, each said branch being receivedand translating within a respective one of the distinct lumens.

An assembly is also provided, which includes a medical tube. The medicaltube has a proximal region and a distal region. A primary lumen extendsthrough the medical tube in both said proximal and distal regionsthereof. At least one secondary lumen extends in the distal region ofthe medical tube and is separated from the primary lumen by an interiorwall of the medical tube. The secondary lumen is configured as a channelsubstantially open to a space outside the medical tube. The primary andsecondary lumens are in fluid communication via at least one opening inthe intermediate wall.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a clearance apparatus coupled to amedical tube.

FIG. 2 is a perspective view of a medical tube with openings (slits inthe illustrated embodiment) in the sidewall of the tube extending alonga portion of the length of the tube.

FIG. 2a is a close-up perspective view of a distal end of the medicaltube of FIG. 2.

FIGS. 3-5 illustrate medical tubes having variable cross-sections alongtheir respective lengths.

FIG. 3 is a side view of an exemplary partitioned medical tube asdescribed herein.

FIG. 3a is a cross-sectional view of the medical tube of FIG. 3 takenalong line A-A therein.

FIG. 3b is a cross-sectional view of the medical tube of FIG. 3 takenalong line B-B therein.

FIG. 3c is a cross-sectional view of the medical tube of FIG. 3 takenalong line C-C therein.

FIG. 4 is a side view of another exemplary partitioned medical tube asdescribed herein.

FIG. 4a is a cross-sectional view of the medical tube of FIG. 4 takenalong line A-A therein.

FIG. 4b is a cross-sectional view of the medical tube of FIG. 4 takenalong line B-B therein.

FIG. 5 is a side view of another exemplary partitioned medical tube asdescribed herein.

FIG. 5a is a cross-sectional view of the medical tube of FIG. 5 takenalong line A-A therein.

FIG. 5b is a cross-sectional view of the medical tube of FIG. 5 takenalong line B-B therein. The distal region (corresponding to thecross-section in this figure) includes perforations through the sidewall of the medical tube as seen in FIG. 5.

FIG. 6 is a perspective view of a partitioned distal region of a medicaltube with apertures in the sidewall thereof along a portion of itslength.

FIG. 7 is a cross-sectional view of the partitioned region of themedical tube shown in FIG. 6 taken along line 7-7 therein.

FIG. 8 is a cross-sectional view of an alternative embodiment of themedical tube shown in FIG. 6.

FIG. 9 is a cross-sectional view of a partitioned medical tube or regionthereof according to another embodiment as described herein.

FIG. 10 is a cross-sectional view of a partitioned medical tube orregion thereof according to another embodiment as described herein.

FIG. 10a is a cross-sectional view of a distal partitioned region of amedical tube according to yet another embodiment as described herein,wherein secondary lumens are in the form of channel U-shaped channelsthat are fully open to lateral space exterior to the medical tube.

FIG. 10b shows a perspective view of the partitioned region of themedical tube shown in FIG. 10 a.

FIG. 10c shows a longitudinal cross-section of the medical tube shown inFIG. 10 a, wherein the primary lumen undergoes a convergence in atransitional region between an unpartitioned region (to the left in thefigure) and the partitioned region shown in FIG. 10 a.

FIG. 11 is a cross-sectional view of a partitioned medical tube orregion thereof according to another embodiment as described herein.

FIG. 12 is a cross-sectional view of a partitioned medical tube orregion thereof according to still another embodiment as describedherein.

FIG. 13 is a cross-sectional view of a partitioned medical tube orregion thereof according to still another embodiment as describedherein.

FIG. 14 is a cross-sectional view of a partitioned medical tube orregion thereof according to still another embodiment as describedherein.

FIG. 15 is a cross-sectional view of a partitioned medical tube orregion thereof according to still another embodiment as describedherein.

FIG. 16 is a cross-sectional view of a partitioned medical tube orregion thereof according to still another embodiment as describedherein.

FIG. 17 is a side view of a clearance member according to an embodimenthereafter described.

FIG. 17a is a rear perspective view of the clearance member of FIG. 17.

FIG. 17b is a close up rear perspective view of the distal end of theclearance member of FIG. 17.

FIG. 17c is a front view taken from the distal end of the clearancemember of FIG. 17.

FIG. 18 is a rear perspective view of a clearance member according toanother embodiment hereafter described.

FIG. 19 is a rear perspective view of a clearance member according toyet another embodiment hereafter described.

FIG. 20 is a rear perspective view of a clearance member according toyet another embodiment hereafter described.

FIG. 21 is a close up rear perspective view of a distal end of aclearance member according to yet another embodiment hereafterdescribed.

FIG. 22 is a cross-sectional view as in FIG. 8 showing a multi-branchedclearance member disposed within the respective lumens of the medicaltube.

FIG. 23 is a cross-sectional view as in FIG. 7 showing a multi-brancheda clearance member disposed within the respective lumens of the medicaltube.

FIG. 24 is a rear perspective view of a clearance member according toyet another embodiment hereafter described.

FIG. 25 is a close up rear perspective view of a distal end of theclearance member of FIG. 24.

FIG. 26 is a close up rear perspective view of a clearance memberaccording to yet another embodiment hereafter described.

FIG. 27 is a close up rear perspective view of a clearance memberaccording to yet another embodiment hereafter described.

FIG. 28 is a close up rear perspective view of a clearance memberaccording to yet another embodiment hereafter described.

FIG. 29 is a close up rear perspective view of a clearance memberaccording to yet another embodiment hereafter described.

FIG. 29a is a close up front perspective view of a clearance memberaccording to yet another embodiment hereafter described.

FIG. 29b is a close up front perspective view of a clearance memberaccording to yet another embodiment hereafter described.

FIG. 30 is a perspective view of a clearance member according to stillanother embodiment hereafter described.

FIG. 31 is a distal-end view of the partitioned medical tube of FIG. 9showing a loop-shaped clearance member disposed within a primary lumenof the medical tube adjacent its distal end.

FIG. 32 is a distal-end view of a partitioned medical tube or distalregion thereof according to still another embodiment showing aloop-shaped clearance member disposed within a primary lumen of themedical tube adjacent its distal end.

FIG. 33 is a cross-sectional view of the partitioned medical tube ofFIG. 11 showing a loop-shaped clearance member disposed within a primarylumen of the medical tube.

FIG. 34 is a side view of a clearance apparatus coupled to a medicaltube having a partitioned distal region, showing a guide member and aclearance member advanced within the medical tube, according to anembodiment hereafter described.

FIG. 35 is a close-up side view of the distal region of the medical tubeillustrated in FIG. 34, showing a clearance member of the clearanceapparatus having respective branches corresponding to individual lumensof the partitioned distal region of the medical tube fully insertedtherein.

FIG. 36 is a close-up side view as in FIG. 35, but with the clearancemember (branches) partially withdrawn.

FIG. 37 is a close up perspective view of an embodiment of the thumbgrip positioned along the medical tube of the embodiment illustrated inFIG. 34 as hereafter described.

FIG. 38 is a close up perspective view of the thumb grip shown in FIG.37 with a tab of a restraining element in a restraining portion of thethumb grip in a resting position.

FIG. 39 is a perspective view of a clearance apparatus according to anembodiment hereafter described.

FIG. 40 is a perspective view of a clearance apparatus according toanother embodiment hereafter described, which has no separate proximalguide tube. The guide tube shown is in an expanded configuration.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

As used herein, the terms proximal and distal are generally to beconstrued with reference to a patient that has been or is to be fittedwith a medical tube, such as a chest tube. For example, the distal endor region of a medical tube (e.g. chest tube) is that end or region thatis to be inserted into or disposed more adjacent (e.g. within) thepatient during use, as compared to the opposite end or region of themedical tube (e.g. chest tube). Similarly, a distal element (or thedistal side or region of an element) is nearer to the patient, or to thedistal end of the chest tube, than a proximal element (or the proximalside or region of an element). Also herein, the “terminal” end of atube, wire, or member refers to its distal end.

FIG. 1 shows a representation of a clearance apparatus 101 coupled to anexemplary medical tube 102 that is partitioned near its distal end 104.The medical tube 102 has at least one lumen and one or more openings 123in fluid communication with one or more lumens within the tube 102. Inthe embodiment of FIG. 1, the medical tube includes only one lumen. Thelumen extends from or near the distal end 104 to the proximal end 103.The openings 123 extend from at or near the distal end 104 along aportion of the length of the medical tube 102. In use fluid can be drawninto the lumen by capillary action or a pressure gradient (e.g. via aconnected vacuum/suction source, vacuum pump, compressed bulb, or othermeans). FIGS. 2 and 2 a more clearly illustrate the medical tube 102with openings 123 along a portion of the length of the medical tube nearits distal end 104. The medical tube 102 can be attached at its proximalend 103 to a clearance apparatus 101. Preferably, the medical tube 102is made from a material having elastic properties, such as silicone,which will help ensure a fluid-tight seal. A flexible, elastic medicaltube 102, e.g. made from silicone, also will result in reduceddiscomfort for the patient compared to more rigid medical-tubematerials, such as polypropylene or polyethylene. However, if desiredthese and other rigid materials may be used. Other materials, includingvarious thermoplastics and thermosets, also may be used in place ofsilicone, if desired. Preferably, the medical tube 102 is made from aclear (i.e. transparent or substantially transparent) plastic material,so the operator of the clearance apparatus 101 described herein canvisualize any clot material or other debris therein, as well as itsremoval as described below. Aspects and embodiments of the medical tube102 hereafter described can be applied directly or with minor androutine modifications to clear obstructive debris from a variety ofmedical tubes used in different applications, for example chest tubes,catheters, surgical drain tubes to drain fluid from other structures ororifices, endotracheal tubes, feeding tubes, gastric tubes, or tubes todeliver material to or from the alimentary tract, etc.

Exemplary embodiments of partitioned medical tubes will now be morefully described. As seen in FIGS. 3-5, medical tubes 102 can be providedthat vary in cross-section along their lengths. In one embodimentillustrated in FIGS. 3-3 c, a medical tube 102 having a generally roundor circular perimeter (circumference) can include a plurality of regionshaving different cross-sections, each region having a respective numberand arrangement of lumens or channels therein. The embodimentillustrated in FIGS. 3-3 c includes three distinct regions: a proximalregion whose cross-section is shown at FIG. 3 a, an intermediate regionwhose cross-section is shown at FIG. 3 b, and a distal region whosecross-section is shown at FIG. 3 c.

The proximal region constitutes a single lumen such that this region isconfigured as a conventional tube. As shown in FIG. 3 a, the medicaltube 102 in this region is substantially hollow having a single lumen ofopen cylindrical cross-section. As shown in FIG. 3b the intermediateregion is divided into four substantially equivalent wedge-shaped lumensarranged symmetrically as shown. As shown in FIG. 3 c, in the distalregion slits or apertures are disposed along the length of the tube 102through its outer wall so that the wedge-shaped lumens in theintermediate region give way to correspondingly arranged andsimilarly-shaped channels that are open laterally to the spacesurrounding the tube 102 adjacent the exterior surface thereof, throughthe aforementioned slits or apertures. It is to be noted that as usedherein, the term ‘lumen’ includes both enclosed passages, which are notopen laterally to the outside of the medical tube, as well as channels,which are passages that are open to the outside via slits, apertures orother openings that provide fluid communication through the wall of themedical tube. A lumen also can be open to an adjacent lumen within themedical tube via slits, apertures or other openings, whether or not itis also open to the outside through the wall of the medical tube.

In another embodiment illustrated in FIGS. 4-4 b, the medical tube 102can be round in shape along a portion of its length near its proximalend 103 and transition into a flattened shape along a portion of itslength near its distal end 104. This type of medical tube can bereferred to as a flat channel drain. As shown in FIG. 4a taken alongline A-A in FIG. 4, a first region of the medical tube 102 in thisembodiment has a single lumen of open cylindrical cross-section similarto a conventional tube. But as one proceeds along its length toward thedistal end, the medical tube 102 in this embodiment transitions fromthat of the first region described above adjacent the proximal end 103to a second region adjacent the distal end 104, which has a flattened,oblong-shaped cross-section featuring two flat longer sides and tworounded shorter sides. FIG. 4 b, taken along line B-B in FIG. 4, shows across-section of the medical tube 102 in this second region wherein thetube is partitioned into four distinct channels, two of which aresubstantially rectangular in cross-section and disposed opposite oneanother adjacent the opposed flat sides of the tube, and two of whichare substantially semicircular in cross-section and disposed oppositeone another adjacent the opposed curved sides. In the illustratedembodiment each of the channels is open to the environment immediatelysurrounding the tube via respective slits or apertures that providefluid communication through the tube wall.

Yet another embodiment is illustrated in FIG. 5, which also shows a flatchannel drain embodiment of a medical tube 102. The first, proximalregion in this embodiment whose cross-section is shown in FIG. 5a takenalong line A-A in FIG. 5, is similar to the preceding embodiment; i.e.it is a single lumen having a cylindrical cross-section as in aconventional tube. However, unlike the preceding embodiment the secondregion here, whose cross-section is shown at FIG. 5b taken along lineB-B in FIG. 5, has a single closed lumen whose cross-section is oblongand substantially ovoid in shape, having flat sides and curved sidesthat are parallel to the respective flat and curved outer walls of thetube in this region. A plurality of longitudinally-extending ribs aredisposed along the length of one flat side of the oblong lumen in thesecond region of the medical tube 102 in this embodiment, definingintermediate channels therebetween. These ribs may impart a degree offlexural strength to the medical tube 102 in the second, flat-channelregion. They may also aid in maintaining a channel or channels for fluidflow in the instance where the tube becomes kinked or crushed.

FIGS. 6-7 illustrate partitioned medical tube 102 according to a furtherembodiment. Specifically, FIG. 6 shows the distal end of a medical tube102, which is partitioned into four substantially equivalent quadrantlumens 105 arranged symmetrically as shown, each having an arcuate outerwall radially distant from the longitudinal axis of the tube 102, and alongitudinally-extending slot 111 opposite the arcuate wall adjacent theaxis. As better seen in FIG. 7, which shows a cross-section taken alongline 7-7 in FIG. 6, the quadrant lumens 105 are separated and defined bysubstantially orthogonally, longitudinally-extending radialcross-members that substantially form a cross or plus sign (+) whenviewed end-on. In this embodiment the slots 111 communicating with eachof the respective lumens 105 are substantially circular incross-section. As will be described below, in preferred embodiments theslots 111 can accommodate respective guide members (e.g. guide wires)for actuating, as by translation, associated clearance members withinthe respective lumens 105.

FIG. 8 illustrates a cross-section similar to that in FIG. 7 exceptwithout the aforementioned slots 111, which may be undesirable orunuseful in case no guide member/wire is to be accommodated therein forclearing the respective lumens 105. In a further alternative (notshown), fewer than all (for example only one) of the lumens 105 may haveassociated slots 111.

In another embodiment illustrated in FIG. 9, a medical tube 102 orportion thereof can include a cross-section with a primary lumen 112disposed at the center and coaxial with the central axis of the tube102, and a plurality of secondary lumens 105 (which can be channels openlaterally to the outside as illustrated) positioned about the outercircumference of the primary lumen 112. In FIG. 9, four secondary lumens105 are arranged circumferentially and aligned 90° apart formingessentially arcuate channels spaced apart adjacent the outercircumference of the primary lumen 112. In FIG. 9 (as well as in FIGS.6-8) openings 123 penetrate through the side wall of the medical tube102 and extend along a length of the tube 102 at least in the vicinityof the pictured cross-section; e.g. from at or near the distal end 104.The openings 123 provide fluid communication between each secondarylumen 105 and the external environment adjacent the opening. Theembodiment illustrated in FIG. 10 is similar to that of FIG. 9, with theaddition of openings 113 through the wall defining the primary lumen 112to provide fluid communication between the primary lumen 112 and each ofthe secondary lumens 105.

FIGS. 10a-10c illustrate a further embodiment of a medical tube 102having a partitioned region at the distal end of the tube. In thisembodiment the secondary lumens 105 are configured as U-shaped channelsthat are fully open to the space laterally adjacent and outside themedical tube. In the partitioned region, each of the secondary lumens105 is in fluid communication with a centrally-disposed primary lumen112 via pluralities of respective openings 113 spaced longitudinally inthe walls separating the primary lumen 112 from each respective lumen.The partitioned region is located remote from the proximal end of themedical tube 102. Beginning from a location proximal to the partitionedregion, preferably from the proximal end of the medical tube, theprimary lumen 112 has a cross section greater than that of the primarylumen 112 in the partitioned region; preferably in this location theprimary lumen 112 is the only lumen in the tube and consequently canhave a maximal cross section suitable for efficient drainage. As theprimary lumen 112 extends distally from the aforementioned location itreaches a transition region where its cross section converges from theaforementioned maximal cross section to a reduced cross section. Theconvergence of the primary lumen makes room for secondary lumens 105 tobe positioned in the tube 102 in the partitioned region, for examplespaced laterally about and extending parallel to the primary lumen 112.In this embodiment, the partitioned region is disposed distally in themedical tube, preferably adjacent the distal end, and configured to beimplanted within the body cavity or orifice of the patient requiringdrainage. The secondary lumens 105 serve to aid fluid drainage into theprimary lumen 112, which may be connected in-line with a vacuum sourceto draw collected fluids and other debris from the body cavity/orifice.Because only the primary lumen 112 is fully enclosed about its perimeterit is the primary location where obstructions are most likely to form.Accordingly, active clearance of only the primary lumen 112 should beeffective to maintain tube patency. This embodiment avoids multiplerelatively small-diameter lumens, e.g. as in the intermediate region ofthe medical tube in FIG. 3, where much of the tube clogging wouldtypically occur.

In this embodiment the longitudinally-variable primary lumen 112 may becleared by any appropriately sized clearance member. More optimalclearance may be achieved using a clearance member 107 that can adjustto the cross section of the primary lumen 112 as it transitions from themedical tube 102 proximal end 103 to distal end 114. Clearance members107 shown in FIGS. 20 and 26-29 b can be manufactured from spring steelor shape memory alloy such as Nitinol so that lateral compressive forcesact on the clearance member 107 as it advances through a region wherethe lumen transitions from larger to smaller cross-section, therebydeforming the clearance member so that it conforms to an overall smallercross-section complementary to that of the smaller-diameter region ofthe lumen 112. The clearance members of FIGS. 26-27 utilize branches orwires that extend laterally and are cantilevered from the guide member109 or otherwise from a central portion of the clearance member. Theclearance members of FIG. 28 is a spiral-wound member, such as a wire,which can be made of elastic shape-memory material having a restingconformation slightly larger than the largest cross- section or diameterto which it must conform in the lumen 112 in use. The clearance membersof FIGS. 29-29 b are wire-form clearance members, formed of one or aplurality of shaped wires that are bent or formed so that together theyform an overall three-dimensional structure; for example a bulb or whiskin FIG. 29, an oblong spheroid in FIG. 29a and an ellipsoid in FIG. 29b. These wire-form clearance members also are preferably formed from ashape-memory, elastic material such that in their resting condition theyconform to an overall cross-section or diameter slightly larger than thelargest cross-section or diameter to which they must conform in use. Ineach case, the elasticity of the clearance member allows it to conformto different cross-sections or diameters of the primary lumen 112, or atleast to adjust to the available cross-section within the lumen at agiven location, to facilitate clearance of different regions. Forexample, the clearance member according to any of the above-describedembodiments can conform to the smaller cross-sectional region of a lumen112 (e.g. at or adjacent a distal end of a medical tube 102), and uponwithdrawal through the tube 102 into a larger cross-sectional region ofthe primary lumen 112, the elastic and/or shape memory properties of theclearance member will tend to return it to approximately its originalshape, such that it will assume a conformation having a larger overallcross-section conforming to the larger-diameter region of the lumen 112.By ‘conform’ it is not meant that the cross-section of the clearancemember necessarily matches or is complementary to that of the lumen 112(though this is one possible embodiment, particularly when the lumen hasa circular cross-section). Rather, ‘conform’ simply means that thecross-section of the clearance member expands to adapt to the availablecross-sectional area within the lumen at a given location.

In addition to its ability to conform to a variable cross-sectionprimary lumen 112, clearance members formed of elastic material as abovedescribed also can conform to kinks and constrictions that may beimparted to the medical tube 102, and to the primary lumen 112 therein,as a result of bending to conform to or navigate body structures andorgans within the body of a patient. This feature may prove useful forclearing a medical tube 102 that follows a tortuous path.

In an alternative embodiment to that illustrated in FIGS. 10a -10 c, theprimary lumen 112 may have an internal cross-section that staysconsistent from the proximal end of the medical tube to the distal endof the medical tube. It can be appreciated that in this configurationthe wall thickness in the proximal region that does not have secondarylumens will become thicker. Alternatively the overalldiameter/cross-section of the medical tube in the proximal region willbe smaller than in the region having secondary lumens.

FIG. 11 shows an additional embodiment, wherein the cross-section of amedical tube or region thereof has three lumens: a primary lumen 112having a semi-circular cross-section, constituting substantiallyone-half of the total cross-sectional area of the tube in this region,and two quadrant or secondary lumens 105 in the form of channels open tothe outside constituting the opposite half of the overall tubecross-section. Openings 123 are positioned along a portion of theexterior wall of the medical tube 102 adjacent each secondary lumen 105to provide fluid communication between each such lumen 105 and theexternal environment. Perforations or openings 113 in the wallseparating the primary lumen 112 from each of the secondary lumens 105provide fluid communication between each of the secondary lumens 105 andthe primary lumen 112.

FIGS. 12-16 illustrate further embodiments of medical tubes 102configured substantially as flat-channel drains. For example, FIGS.12-14 show similar embodiments wherein the tube 102 has a substantiallyellipsoid cross-section with a central primary lumen 112 having asubstantially circular cross-section concentric with the longitudinalaxis of the tube 102. A pair of secondary lumens 105, each having asubstantially trapezoidal-shaped cross-section with curved walls andbeing the mirror image of the other, are arranged on opposite sides ofthe primary lumen 112. In each of the illustrated embodiments of FIGS.12-14, openings 123 in the side wall of the tube 102 provide fluidcommunication between each of the secondary lumens 105 and the exteriorenvironment adjacent the medical tube 102, such that the secondarylumens 105 are configured as channels. In the embodiments of FIGS. 13and 14, openings 113 (e.g. slots or perforations) are provided in thewalls separating the primary lumen 112 from the secondary lumens 105 toprovide fluid communication between them. Pluralities of such openingscan be spaced periodically and longitudinally along the medical tube102. Alternatively, the openings 113 an be configured as slots thatextend a partial or appreciable length of the medical tube, preferablyat or adjacent its distal end. The embodiment shown in FIG. 14 includesadditional openings 113 in the side wall of the medical tube between theprimary lumen 112 and the external environment, thus providing fluidcommunication therebetween. Again, these openings can be configured anddisposed similarly as described above.

The embodiment of the medical tube 102 shown in FIG. 15 has asubstantially rectangular cross-section. A substantiallyrectangular-shaped primary lumen 112 is centrally positioned in the tube102 with a pair of substantially semi-circular shaped disposed onopposite sides of the primary lumen 112 adjacent the short sides of themedical tube when viewed in cross-section. Each semi-circular shapedlumen 105 can be provided with fluid communication with the exteriorenvironment outside the tube via openings 123 in the side wall of thetube, for example in the vicinity of its distal end that would beinserted within a patient cavity during use, in order to drain fluidspresent in that vicinity. Also as before, internal openings 113 can beprovided in the walls separating the primary lumen 112 and eachsecondary lumen 105. Still further, additional openings 113 can beprovided in the long-side walls of the tube 102 to provide communicationbetween the primary lumen 112 and the external environment. Suchopenings 113 and 123 can be disposed and configured in the tube of thisembodiment similarly as already described.

Each of the aforementioned medical tubes has possessed a symmetriccross-section such that the left side is a mirror image of the rightside when viewed in cross-section. However, asymmetric tubes (whenviewed in cross-section) are also within the scope of this disclosure.In one alternative embodiment shown in FIG. 16, an ovoid-shaped medicaltube 102 can include, e.g., a circular-shaped primary lumen 112 offsetfrom the center of the medical tube so that its axis is not the same asthe central axis of the medical tube. A substantially oval-shapedsecondary lumen 105 is positioned adjacent the opposite roundedside-wall of the medical tube 102 in the illustrated embodiment, whereinan opening 123 in the side wall of the tube 102 provides fluidcommunication between the external environment and the lumen 105.Additionally, openings 113 in the outer walls of the tube 102 adjacentthe primary lumen 112, as well as in the interior wall separating thetwo lumens, provide fluid communication between the secondary lumen 105,the primary lumen 112 and the external environment. Again, theseopenings 113 and 123 can be disposed and configured as alreadydescribed.

Regardless of the relative positioning and orientation of the pluralityof distinct lumens running parallel within a medical tube or within aregion of a medical tube, a multi-branched clearance member can beconfigured to match the lumen configuration in order to providesimultaneous clearance of the plurality of lumens. Returning for exampleto the multi-lumen configurations illustrated in FIGS. 7 and 8, amulti-branch clearance member, e.g. as illustrated in FIGS. 17-17 c canbe configured to provide respective clearance elements corresponding toand aligned with each of the respective lumens in order to provideeffective and simultaneous clearance of each. The clearance member 107(FIG. 17) can be provided, for example, at or formed as part of thedistal end of an elongate guide member 119 that can be actuated from amore proximate location relative to the patient. Any suitable actuationmechanism effective to translate or otherwise actuate the clearancemember 107 in or through the correspondingly and respectively arrangedlumens for clearance thereof can be used. One exemplary actuation deviceis disclosed, for example, in U.S. Pat. No. 7,951,243, which isincorporated by reference. However, other suitable actuation mechanismsmay be advantageously used.

Returning to the embodiment of FIGS. 17-17 c, the clearance member 107is disposed at and in a preferred embodiment integrally formed with oras the distal end of an elongate guide member 119, which can bereversibly advanced into and through the medical tube 102 to break upand/or withdraw obstructive debris therefrom (also described below). Inone embodiment, the guide member 119 can be in the form of a guide wire,and the clearance member 107 can be formed by the guide wire, or by aplurality of wires that are intertwined to provide the guide member 119but which are unwound and separated to provide distinct branches 109 ofthe clearance member 107 as hereafter described. In the illustratedembodiment, the clearance member 107 is configured for use in a medicaltube 102 that is partitioned into a plurality of lumens 105 configuredsubstantially as illustrated in the cross-sections of FIG. 7 or 8, atleast at or adjacent the tube's distal end 104.

Referring now to FIG. 17, the exemplary multi-branched clearance member107 has a plurality of wires that are bundled together at a proximal end110 where it meets (or transitions from) the guide member 119. Theindividual wires can be intertwined, twisted, wound into a helix orparallel to one another. In an alternative embodiment, the wires may bebundled at their proximal end 110 by a retaining member that holds thewires together, or they may be welded together. In one of theaforementioned configurations the bundled wires may form the guidemember 119 itself. The individual wires are separated into four distinctbranches 109 on approach of the distal end 108 of the clearance member107, each constituting a respective clearance element aligned andadapted to clear an associated one of the lumens in the medical tube102. That is, the wires are separated such that the resulting branches109 are spatially arranged to fit within the lumens of acomplementarily-partitioned medical tube 102. As seen in FIGS. 17a -17c, in the illustrated embodiment the terminal end of each individualwire/branch 109 is wound to form a loop 107 a. The diameter of each loop107 a can be selected, for example, to substantially correspond to thecircumference of the inner wall of a corresponding lumen 105 of themedical tube 102 to which the clearance member 107 will be fitted, asdescribed in more detail below. Other configurations besides loops arealso contemplated to match the cross-sectional perimeter shape of thelumens to be cleared, as will also be described below. The length of theclearance member 107 is preferably dimensioned to correspond to a lengthof a partitioned region of the medical tube 102 to allow the clearancemember 107 to break up and/or withdraw debris from within thepartitioned portion of the medical tube 102, for example upontranslation from a fully-advanced state within the aforesaid partitionedregion to a substantially fully withdrawn state relative to said region.

In a further embodiment, the terminal end of each individual wire branch109 of the clearance member 107 can include a sphere 107 b as shown inFIG. 18. The diameter of each sphere 107 b again is preferably selectedto provide a sphere whose cross-sectional dimension substantiallycorresponds to that of the lumen 105 of the medical tube 102 in which itwill be actuated to clear debris. The embodiment of FIG. 18 alsoillustrates bundling the wires of the clearance member 107 at theirproximal end 110 by twisting the wires together with a single-wire guidemember 119.

Similar to FIG. 18, FIG. 19 illustrates an embodiment with spheres 107 bdisposed or formed at the terminal ends of the branches 109 of theclearance member 107. As compared to the embodiments in FIGS. 17 and 18,the individual wires of the embodiment of FIG. 19 are arranged fartherapart from each other, as would be appropriate in case of a medical tubehaving a corresponding and complementary multi-lumen configuration. Inthis embodiment the lengths of the branches 109 of the clearance member107 are also shorter than in earlier-illustrated embodiments, whichwould correspond to a similarly-shorter multi-lumen region of a medicaltube 102 in which the clearance member 107 is to be effective to cleardebris. It will be appreciated that the number, arrangement, spacing andlength of the branches 109 of a multi-branch clearance member 107 asherein described can be selected to correspond to the complementaryfeatures in the multi-lumen region of the medical tube 102 to becleared. Additionally, FIG. 19 shows an embodiment where the wiresforming the branches 109 are bundled at the proximal end 110 of theclearance member 107 by a retaining member 127 that holds the wirestogether.

In the embodiments of FIGS. 17-19, the wires of the clearance member 107are arranged to correspond with particular lumens of a partitionedmedical tube 102. FIG. 20 illustrates another embodiment of a clearancemember 107 comprising a plurality of branches 109 that are bundledtogether at their proximal end 110 by a retaining member 127, but whichradiate away from one another and away from a central axis of theclearance member 107. In this embodiment, the branches 107 are made of aflexible, preferably shape-memory material so that they retain a degreeof rigidity and stiffness, yet can be bent to follow the contour of aparticular lumen upon being forcibly advanced therein. Configured inthis manner, the individual branches 107 are not arranged to correspondto complementarily arranged lumens 105. Instead, upon advancement towardand into a multi-lumen region of a medical tube 102 respective ones ofthe branches 107 will encounter and enter respective lumens, and uponfurther advancement will be forcibly conformed to follow the pathsdefined by those lumens. Upon continued advancement and subsequentretraction into/from those lumens, or alternatively upon other actuationsuch as vibration, sonication, etc., each branch 107 can effectivelyclear a respective lumen 105.

FIG. 21 shows another exemplary embodiment of a clearance member 107 fora partitioned flat-channel drain, this one configured to clear thelumens within the medical tube configuration illustrated in FIG. 15. Inthis embodiment, the terminal ends of the branches 109 aligned to clearthe secondary channels 105 in FIG. 15 are configured as loops 107 a,which can approximate the perimeters of the respective channels 105 incross-section. Capsules 107 c are at the terminal ends of the branchesthat are arranged to be inserted into primary lumen 112 in FIG. 15. Aswill now be appreciated, multiple branches 109 and their associatedclearance elements at their distal ends (if present) can be configuredand arranged to jointly enter and clear a common lumen. Alternatively,the clearance member 107 of this embodiment could be utilized to clear afour-lumen medical tube 102, such as for example the one illustrated inFIG. 4. In this embodiment, the branches 109 having the capsule 107 cclearance elements would be aligned and utilized to enter and clear thetwo rectangular-shaped lumens on the longer sides of the medical tube102 in FIG. 4, while the other two branches 109 having the loops 107 awould be aligned and utilized to enter and clear the twosemicircular-shaped lumens adjacent the shorter sides of the medicaltube 102. The dimensions of each loop 107 a and capsule 107 c arepreferably selected to substantially correspond to the dimensions of theinner wall of a lumen 105 of the medical tube 102 to which the clearancemember 107 will be fitted. It can be appreciated that for clearance ofthe lumen configuration of FIG. 15 a clearance member with fewerclearance elements of appropriate shape may be used.

FIGS. 22 and 23 show cross-sections of the partitioned medical tubes ofFIGS. 8 and 7, respectively, wherein the clearance member 107 of FIG. 17has been inserted such that its respective branches 109 extend into thecorrespondingly-arranged lumens 105. As discussed above, each loop 107 ais preferably selected to substantially correspond to the circumferenceor other lateral dimension(s) of the inner wall of the associated lumen105. Each loop 107 a also provides a substantially unobstructed pathwaythrough each lumen 105 where the loop is located regardless whether theclearance member 107 (and accordingly the loop 107 a) is at rest orbeing actuated to clear debris within the lumen 105. Additionally, inthe embodiment of FIG. 23 the guide member 119 is received within andextends through the slot 111 associated with each of the lumens 105within the tube 102. This arrangement helps guide translation of theclearance member 107 and its associated branches 109 through therespective lumens in the multi-lumen region of the tube.

When actuating the multi-branched clearance member 107, it is preferablynot retracted so far that the branches 109 thereof become entirelywithdrawn from their respective lumens 105. This is because realignmentand insertion of the branches 109 within the respective lumens 105 willbe difficult and perhaps impossible in clinical situations where thetube 102 is inserted within a patient and visualization of themulti-lumen region within the tube may be impossible or obscured.Alternatively, even if the multi-lumen region can be visualized it couldbe difficult to realign all branches 109 with their associated lumens105 for reinsertion. For example, FIGS. 35-36 (discussed in more detailbelow) illustrate side views of a multi-branch clearance device 107 asdiscussed above with respect to FIGS. 22-23 at different stages ofadvancement within a distal, multi-lumen region of a medical tube 102.In FIG. 35 the clearance member 107 is fully inserted so that itsbranches 109 penetrate to near the distal end of the individual lumens;whereas in FIG. 36 the clearance member 107 has been withdrawn so thatthe branches 109 are nearly but not quite fully withdrawn from themulti-lumen region. It is desired not to withdraw the multi-branchedclearance member 107 to a greater extent than illustrated in FIG. 36;i.e. to such an extent that the branches 109 would be entirely withdrawnfrom their associated lumens in the multi-lumen region of the medicaltube 102.

The embodiments illustrated in FIGS. 24 and 25 illustrate an embodimentof a clearance member 107 for use in a flat channel drain that includesregions with different cross-sections, for example, as illustrated inFIG. 5. In this embodiment, the terminal portion of the guide member 119is wound to form an oblong-shaped loop 107 d at its distal end. The loop107 d is shaped to correspond to the perimeter dimensions of the distalregion of the medical tube shown in FIG. 5, and would be effective toclear debris therein. Separately, a second, circular clearance member124 is positioned more proximally and attached along the guide member119. The clearance member 124 is shaped to correspond to the perimeterdimension of the proximal region of the medical tube in FIG. 5, andwould be effective to clear debris in that region. As will beappreciated, actuation of the guide member 119 from a proximal locationwill simultaneously actuate (e.g. translate, sonicate, vibrate, etc.)both the clearance members 107 and 124 in this embodiment, thussimultaneously clearing two longitudinally distinct regions of themedical tube, each having its own respective cross-section. It is to benoted that while the clearance member 107 in this embodiment isconfigured as a loop for a single-lumen distal region having oblongcross-section, the clearance member 107 also could be a multi-branchedmember as above described for clearing a multi-lumen region of themedical tube. Moreover, the loops illustrated in FIG. 24 are exemplaryand correspond to the particular proximal and distal regions of themedical tube in FIG. 5. But it is to be appreciated that the loops canpossess any suitable shape and may be arranged at suitable spacings tocorrespond to the particular medical tube to be cleared. Additionally,multiple clearance members, two or more, may be used in eachlongitudinally distinct region to achieve clearance along the length ofthe region using a given actuation.

FIGS. 26-29 illustrate additional embodiments of clearance members 107that are configured to be insertable into a lumen of a medical tube 102,such as the primary lumen 112 shown in FIGS. 9-16. For example, theembodiment of FIG. 26 utilizes a wound spiral guide member 119.Groupings of wires or bristles 125 can extend laterally from betweenadjacent turnings of the guide member 119 and are preferably angledtoward the proximal end of the guide member 119 to provide a wire-brushtype cleaning member 107. In an alternative embodiment, rows of scraperelements 128 can be arranged around the circumference of a guide memberat a distal end 108 of a clearance member 107 as shown in FIG. 27. Inthe illustrated embodiment, each row of scraper elements 128 includesthree wires that extend laterally from the guide member 119 and form ahook at their terminal end. Each wire is angled toward the proximal endof the guide member 119. In another embodiment, a guide member 119 canbe wound turning about an axis at a constant upward angle to form ahelix-shaped clearance member body 109 as shown in FIG. 28. The terminalend of the wound guide member 119 can be capped with a sphere 107 e toform a blunt end. In a further embodiment, FIG. 29 illustrates aclearance member 107 comprising a plurality of wire loops that arebundled and held together by a retaining member 127 to form a whiskshape at a distal end 108 of the clearance member 107. In a furtheralternative embodiment, the clearance member 107 as shown in FIG. 30comprising a sphere 107 e at a terminal end of a guide member 119. Thesphere 107 e may be sized to approximate the internal diameter of around lumen. It may be sized substantially close to the lumen diameter,but with some clearance for the passage of fluid to prevent alteringpressure within the target drainage compartment (e.g. the body orificeor cavity being drained), by a plunger effect. Alternately, it may besize larger than the diameter provided the wall of the lumen is madefrom an elastic material such as silicone, thereby scraping the walls ofthe lumen while simultaneously stretching them to loosen material.Alternatively, it may be sized substantially smaller than the lumen toallow free flow of fluid and material past the sphere. In an alternativeembodiment, the distal end of the clearance member 107 can be in theform of a loop as generally discussed in U.S. Pat. No. 7,951,243, hereinincorporated by reference in its entirety. A clearance member 107configured as any one of the above, or having any alternative suitableconfiguration, can be provided in place of the oblong loop 107 d in theembodiment shown in FIG. 24 so long as it is appropriate to clear theassociated distal region of a medical tube 102.

Alternatively or in addition, the clearance member 107 of each of theembodiments of FIGS. 26-30 can be configured to be insertable into aprimary lumen 112 of a multi-lumen medical tube 102 or of a multi-lumenregion of a medical tube 102, without necessarily requiring additionalbranches 109 to be insertable or inserted in adjacent lumens. Forexample, FIG. 31 shows the partitioned medical tube of FIG. 9 with aloop-shaped clearance member 107 within the primary lumen 112. Theclearance member 107 is preferably selected to substantially correspondto the perimeter dimensions (in this case the circumference) of theinner wall of the lumen 112. FIGS. 32 and 33 show additional examples ofpartitioned medical tubes 102 with a loop-shaped clearance member 107within the primary lumen 112. Notably, no clearance members or branches109 are provided to clear the secondary lumens 109 in these embodiments.While the clearance member 107 embodiments illustrated in FIGS. 31-33provide a substantially unobstructed pathway through the lumens 112,alternative clearance member embodiments may obstruct more of thepathway through the lumens 112. It can be appreciated that multipleclearance members of the same or differing configuration can be deployedalong the length of the lumen.

The guide member 119 and clearance member 107 can be made fromconventional materials including plastics and metals. It is preferredthat the guide member 119 be made from a material having sufficientflexibility that it can reversibly bend to a radius of curvature of fourcentimeters, more preferably three centimeters, more preferably twocentimeters or one centimeter, without snapping or substantiallycompromising its structural integrity. Suitable materials include,stainless steel, titanium-nickel (such as Nitinol), cobalt alloys. Inaddition to being sufficiently flexible to negotiate bends in themedical tube 102 on being advanced/retracted therethrough, the guidemember 119 should preferably have sufficient stiffness or rigidity to bepushed through accumulated clot material within either tube withoutkinking or being caused to double back on itself. The guide member 119may be coated with a friction-reducing material or non-stick material,for example PTFE, FEP, parylene, or silicone, in order to inhibit theadherence of clot material, thrombi or other obstructive debris, thuspromoting better lumen clearance. The guide member 119 may be coatedwith a pharmacologic material. The guide member 119 may be coated withan anti-thrombogenic material. The guide member 119 may be coated withan anti-infective material. Alternatively, the guide member 119 may becoated with a combination of these. The guide member 119 also can have aguide lumen provided in fluid communication with one or more openingsdisposed through the wall of the clearance member 107 or with any or allof its individual branches 109 (not shown) as generally discussed inU.S. Pat. No. 7,951,243, which has already been incorporated byreference. The guide lumen and cooperating openings may be utilized todeliver flushing or irrigation fluid to assist in dislodging anymaterial stuck to the clearance member 107 or its branches 109. Inaddition or alternatively, fluid expelled from the guide lumen throughthe one or more openings may be a solution provided to assist in thedislodgment, dissolution, and/or breakup of the debris. Fluids suitablefor the particular purpose include, but are not limited to,anti-thrombolytic agents, Alkalol™, among others. In still otherembodiments, such fluid may be or include a therapeutic agent such asbut are not limited to antibiotic agents, anti-infective agents,anti-neoplastic agents, and other agents for a variety of purposes,including pain relief, treatment of infection, cancer, or to inducescarring (i.e. pleurodesis). Alternatively to delivering fluids, theguide lumen may be used to detect carbon dioxide in a patient's chestcavity as a means to determine whether there is a puncture in thepatient's lung as generally discussed in the '243 patent.

As previously discussed, the clearance member 107 may be attached to orformed at the distal end of a guide member 119 that can be actuated froma proximal end of the medical tube; e.g. from outside the medical tubeat or adjacent its proximal end. One embodiment of an actuation deviceis disclosed in the '243 patent incorporated above. Briefly, asdisclosed in that patent a medical tube such as a chest tube can beconnected at its proximal end to a shuttle-guide tube, and a shuttletranslatable along the length of the guide tube can be magneticallycoupled to a magnetic guide disposed within the guide tube. The magneticguide is itself coupled to a proximal end (or in a proximal region) ofthe guide member such that translation of the shuttle along the guidetube length outside that tube induces a corresponding translation of theguide member within. Translation of the magnetic guide results intranslation of the attached guide member and correspondingly of anyclearance member at or adjacent its distal end to clear obstructivedebris within the medical tube.

FIGS. 34-40 illustrate further embodiments of a device for actuating theguide member 119, and correspondingly clearance member 107, to clearobstructive debris in medical tubes according to any of the precedingembodiments. For example, referring first to FIG. 34, an actuationdevice includes a handle assembly 114 that is effective to translate theguide member 119, and therefore the clearance member 107, within themedical tube 102, e.g. a chest tube. In this embodiment the medical tube102 can be coupled to the handle assembly 114 via a medical-tube fitting115, which preferably has an internal diameter that is in continuitywith the medical tube 102 at least at the point of attachment. Thehandle assembly 114 can also be connected to a vacuum drainage tube orother suction source (not shown) through a suction fitting 116 disposedat the proximal end of the handle assembly 114. The handle assembly 114itself is substantially hollow or otherwise defines therein a conduit orpassageway between the proximal and distal ends (i.e. betweenmedical-tube and suction fittings 115 and 116, so that debris evacuatedfrom the medical tube 102 can be drawn through the handle assembly 114via a suction source. A guide member 119, e.g. according to any of theembodiments above described, is secured to or within the handle assembly114 at or adjacent the member's 119 proximal end.

The length of the guide member 119 may be calibrated to ensure that theclearance member 107 at its distal end 108 does not extend out of orbeyond the distal end 104 of the medical tube 102. For example, thelength of the guide member 119 and its clearance member 107 togetherpreferably substantially approximate the distance from the guidemember's point of attachment with the handle assembly to just short ofthe distal end of the medical tube 102.

In this embodiment the medical tube 102 or at least a proximal portionthereof near or adjacent the handle assembly 114 is made of a flexiblematerial that is elastically stretchable, such as a suitable elastomeror silicone. The medical tube 102 may be reinforced in this area fore.g. by coil reinforcement or other means such as braiding using metalor polymer wires or strands, to resist breakage and enhance elasticrecoil. Alternatively, an intermediate, elastically stretchable tube canbe interposed and connected in fluid communication between the handlemember 114 and the medical tube 102 via suitable fittings (not shown).The intermediate tube may also be reinforced similarly as describedabove. In either case, preferably a thumb grip 117 is disposed on theoutside of the medical tube 102 (or optionally on the aforementionedintermediate stretchable tube if present) at a location distally remotefrom the handle assembly 114.

In order to clear obstructing material from the medical tube 102, a userwould grasp the medical tube 102 (or intermediate tube if present) at aposition distal from the handle assembly 114, e.g. at the thumb grip117, simultaneously grasp the handle assembly 114, and draw the handleassembly 114 proximally away from where the tube is being grasped withthe other hand. As the effective length of the tubing between the handleassembly 114 and the distal end 104 of the medical tube 102 is increasedwhen the medical (or intermediate) tube is stretched, a normallyin-dwelling clearance member 107 (i.e. one that normally rests withinthe medical tube adjacent its distal end) will be drawn proximallythrough the medical tube. The clearance member 107 can thus clear debrisin the lumen(s) served by the clearance member 107 or its branches 109(if present) by drawing obstructive debris proximally, toward the handleassembly 114. While continuing to hold thumb grip 117 with one hand, theuser can return handle assembly 114 back to its original location andthe elastic portion of the medical tube 102 between thumb grip 117 andhandle assembly 114 will shrink back to its original length, advancingthe guide member 119 and clearance member 107 back to their originalresting position. During this operation, care should be taken not tostretch the medical tube 102 (or its elastic portion) so far that theclearance member 107 becomes completely withdrawn from the partitionedregion of the medical tube. This is because reinsertion of individualwires of the clearance member 107 into respective lumens in thepartitioned region may be difficult as noted above. The user can repeatthese steps to translate the clearance member 107 through thepartitioned region of the medical tube 102, or a portion thereof, inorder to dislodge blood, clots, and other debris that may haveaccumulated along the inner walls of the lumens in the partitionedmedical tube. Loosened blood, clots, and other debris then can drainfrom the medical tube 102 through the fitting 115 into the handleassembly 114, and then through the fitting 116 to the vacuum drainagetubing and into a drainage receptacle (not shown). Suction is generallyapplied to the drainage receptacle to facilitate the drainage along thispathway.

FIG. 35 illustrates an exemplary multi-branch clearance member 107having a plurality of branches 109 disposed in corresponding lumenswithin a multi-lumen distal region of a medical tube 102. Utilizing thestretchable tube/region feature described above, upon expanding theeffective length of the tube the clearance member will be withdrawn fromits resting position adjacent the distal end 108 of the medical tube, toa more proximal position relative to the distal end 108 as shown in FIG.36. According to a preferred embodiment, the elasticity and length ofthe stretchable region/tube can be selected together so that thedifference in its length between its relaxed state and fully-stretchedstate corresponds to the desired maximum degree of withdrawal of theclearance member 107 relative to the distal end of the medical tube 108.In this manner, for example, a multi-branched clearance member 107 canbe assured not to be withdrawn entirely from the multi-lumen region of amedical tube 102 if the aforementioned length difference corresponds toor is just under the length of the multi-lumen region. In an alternativeembodiment the multi-branch clearance member may be positioned in thetube so that it traverses only a portion of the partitioned region(having multiple lumens) in the medical tube when actuated. For examplethe distal end of the clearance member (i.e. of branches 109) may onlytraverse the distal and intermediate regions of the medical tube shownin FIG. 3 (corresponding to the cross-sections taken along lines A-A andB-B therein). Optionally they may be withdrawn only partially into theproximal region corresponding to the cross-section taken along line C-C.When the tube is stretched the clearance member clears the intermediateregion, which is the most likely region for tube clogging to occur inthe configuration shown in FIG. 3.

In an alternative embodiment, a stretch-limiting mechanism can beincorporated to impede unintended complete withdrawal of the clearancemember 107 from the partitioned region of the medical tube 102 if themedical tube 102 is stretched too far as mentioned above. FIG. 37 showsan embodiment of a clearance apparatus 101 similar to that of FIG. 34wherein the thumb grip 117 is equipped with a stretch restraint portion126. A distal end of the thumb grip 117 has an internal diameter thatsubstantially corresponds to the outer diameter of the medical tube 102,thereby enabling securement of the grip 117, and correspondingly therestraint portion 126, to the medical tube 102 via an interference fitor via any other suitable mode of attachment; e.g. use of an adhesive.The medical tube 102 passes through a cylindrical passage in the stretchrestraint portion 126 of the thumb grip 117 from its distal end, andcontinues to the handle assembly 114, where the medical tube 102 iscoupled to the handle assembly 114. As shown in FIG. 38, a restrainingelement such as a ring 131 is housed within the restraint portion 126,and is slidably translatable therethrough along a longitudinal axis ofthe medical tube 102 that passes centrally through the center of thering 131. The ring 131 has an internal diameter that substantiallycorresponds to, or that is even slightly smaller than, the outerdiameter of the medical tube 102, thereby securing the ring 131 in placeon the tube 102 via an interference fit. Alternatively or in addition,adhesives may also be used, for example when the restraining element isnot configured as a ring that receives the tube 102 therethrough but isinstead merely adhered to the surface of the tube 102. The ring 131 hasan outer diameter substantially matching the inner diameter of thecylindrical passage within the stretch restraint portion of the thumbgrip 117 for ease of alignment and translation therein. A tab or slideswitch 132 is formed with or attached to an upper portion of the ring131 and extends through a slot 130 provided in the housing of therestraint portion 126, aligned with its longitudinal axis. In itsresting (unengaged) position, such as when the medical tube 102 or itselastically stretchable region is relaxed and unstretched, therestraining ring 131 is located near the distal end of the restraintportion 126, wherein the tab/switch 132 is disposed at the distal-mostpart of the slot 130. In its engaged position, the restraining ring 131is located near the proximal end of the restraint portion 126, whereinthe tab 132 is reaches and is engaged against the proximal-most part ofthe slot 130.

In use, as the medical tube 102 (or its elastic region) is stretchedfrom the distally-located thumb grip 117 (as by separating the grip 117and handle assembly 114), the tab 132 of the restraining ring 131, whichis fixed on the medical tube, will approach and reach the proximal endof the slot 130. When the tab 132 reaches this point it will inhibitfurther stretching of the medical tube 114 thus inhibiting the clearancemember 107 from being withdrawn from a partitioned region of the medicaltube 102. At a minimum, the progression of the tab 132 toward theproximal end of slot 130 in use can serve as an indicator to theoperator how far the tube has been stretched and, optionally, when tocease further stretching. In this embodiment, for example, the length ofthe slot could be calibrated to the length of a multi-lumen region ofthe medical tube 102 from which it is desired to prevent completewithdrawal of a clearance member 107 at the end of the guide member 119within the tube. It can be appreciated that other mechanical means canbe used to limit the stroke of the clearance member and prevent overstretching. In yet another embodiment, the clearance apparatus 101 mayinclude one or a plurality of adjustable-length guide tubes coupled toor formed as part of the handle assembly 114 for the clearance apparatus101, through which debris evacuated from the medical tube 102 may flowon its way to a suction source. Such adjustable-length guide tube(s) canbe coupled, for example, in-line with and proximal to the medical tubewith the guide member 119 extending at least partially therein, so thatexpansion and contraction of the adjustable-length guide tube canaccommodate cycles of actuation (e.g. advancement and withdrawal) of theguide member 119 as already described. FIGS. 39 and 40 illustrateexemplary embodiments of handle assemblies 114 of clearance apparatus101 having adjustable-length guide tubes associated therewith, in whichthe guide tubes are configured as accordion-style collapsible tubes.

Referring first to FIG. 39, a handle assembly 114 distal and proximalhandle portions 120 and 121 that are longitudinally separable from oneanother. The handle portions 120 and 121 are connected via a proximaladjustable guide tube 122 b that defines a substantially cylindrical andvariable-length passageway therein, which in use will cooperate topartially define the sterile pathway between a medical tube and asuction source. As will be appreciated from FIG. 39, as the handleportions 120 and 121 are separated adjacent accordion elements in thetube 122 b wall will unfold, thus lengthening the guide tube 122 b.Conversely, as the handle portions 120 and 121 are brought together andultimately attached to one another, the accordion elements will fold,thus collapsing the length of the tube 122 b. The handle portions 120and 121 can have respective and facing parking surfaces thatcooperatively engage one another when the portions 120 and 121 areassembled to complete the handle assembly 114. For example, detent tabs,magnets or other reversible coupling structure can be used to secure thehandle elements together when not in use.

A guide member 119 as above described can be disposed within the handleassembly 114, and be secured at its proximal end to the proximal handleelement 121. In this manner, as the length of the adjustable guide tube122 b is increased by separating handle portions 120 and 121, aclearance member 107 at the distal end of the guide member 119 can bewithdrawn from within a medical tube 102 as above described. Conversely,collapsing the guide tube 122 b will advance the guide member 119attached to the handle element 121 through the medical tube 102, e.g. torestore it to a resting or parked position adjacent the medical-tubedistal end 108.

In addition to or instead of the proximal adjustable guide tube 122 b,the clearance apparatus 101 can include a distal adjustable guide tube122 a as seen in FIG. 39. In the illustrated embodiment the distaladjustable guide tube 122 a has accordion elements similarly asdescribed above, and can be expanded and collapsed lengthwise in asimilar manner; i.e. by adjusting the distance between the handleassembly 114 (or at least of the distal handle portion 120, and a fixedpoint along the length of the guide tube 122 a, for example a fitting115 for securing the distal end of the guide tube 122 a to distalstructure, such as a medical tube 102. Again, with the proximal end ofthe guide member 119 secured to the proximal handle portion 121,expansion of the distal guide tube 122 a will result in withdrawal ofthe guide member and clearance member from the medical tube, whereascontraction of the guide tube 122 a will result in advancement.Alternatively, and particularly when the proximal guide tube 122 b isomitted as seen in FIG. 40, the proximal end of the guide member 119 canbe secured within the distal handle portion 120; or in the handleassembly 114 if not separated into portions 120 and 121 case. In analternative embodiment, the guide member 119 may be actuated via aspool-drive mechanism as described in co-pending non-provisional patentapplication Ser. No. 14/624,161 filed on even date herewith, hereinincorporated by reference in its entirety.

Although the invention has been described with respect to certainpreferred embodiments, it is to be understood that the invention is notlimited by the embodiments herein disclosed, which are exemplary and notlimiting in nature, but is to include all modifications and adaptationsthereto as would occur to the person having ordinary skill in the artupon reviewing the present disclosure, and as fall within the spirit andthe scope of the invention as set forth in the appended claims.

What is claimed is:
 1. A device for clearing obstructions from a medicaltube, the device comprising: (i) an adjustable-length tube connected influid communication with a medical tube, the adjustable-length tubebeing elastically stretchable from a relaxed, unstretched state to afully elongated, stretched state; (ii) an elongate guide memberextending through the adjustable-length tube and the medical tube, theguide member being attached at or adjacent to a proximal end thereof tothe adjustable-length tube; and (iii) a clearance member attached to orformed integrally with the guide member, wherein extension of theadjustable-length tube results in withdrawal of the guide memberrelative to the medical tube, and shrinkage of the adjustable-lengthtube back to the relaxed state results in advancement of the guidemember to a resting position within and adjacent to a distal end of themedical tube.
 2. The device of claim 1, the elongate guide member beingattached to the adjustable-length tube via a handle assembly attachedthereto.
 3. The device of claim 1, the clearance member having aclearance element disposed or formed at or adjacent its distal end, theclearance element being configured to match a cross-sectional perimetershape of a lumen in the medical tube.
 4. The device of claim 1, themedical tube having an aperture through a wall of the medical tubeadjacent to a distal end thereof, the clearance member being dimensionedand oriented so that it cannot pass through the aperture.
 5. The deviceof claim 1, the distal end of the medical tube having a partitionedregion.
 6. The device of claim 2, further comprising a thumb gripdisposed on the medical tube at a location distally remote from thehandle assembly, wherein the adjustable-length tube is stretched betweenthe handle assembly and the thumb grip by separating them longitudinallyrelative to the adjustable-length tube.
 7. The device of claim 1,wherein a length and elasticity of the adjustable-length tube areselected so that a difference in its length between said relaxed stateand said fully elongated state corresponds to a desired maximum degreeof withdrawal of the guide member relative to the distal end of themedical tube.
 8. The device of claim 1, the medical tube at leastpartially defining a sterile pathway through which obstructions can beevacuated.
 9. The device of claim 1, the adjustable-length tube and themedical tube together at least partially defining a pathway throughwhich obstructions can be evacuated.
 10. The device of claim 9, thepathway constituting a sterile field.
 11. The device of claim 1, theclearance member being a wire-form clearance member.
 12. The device ofclaim 1, the adjustable-length tube comprising coil reinforcement. 13.The device of claim 2, further comprising an intermediate tube betweenthe handle and the medical tube, the intermediate tube comprising coilreinforcement.
 14. The device of claim 1, further comprising aspring-loaded drainage canister.
 15. The device of claim 1, furthercomprising a fitting on a distal end of the adjustable-length tube. 16.A medical tube having a proximal region and a distal region, a primarylumen extending through both the proximal and distal regions, and atleast one secondary lumen extending in the distal region and separatedfrom the primary lumen by an interior wall of the medical tube, thesecondary lumen being configured as a channel substantially open to aspace outside the medical tube, the primary and secondary lumens beingin fluid communication via at least one opening in the interior wall.17. The medical tube of claim 16, comprising a plurality of secondarylumens extending in the distal region and separated from the primarylumen by at least one interior wall of the medical tube, each of thesecondary lumens being configured as a channel substantially open to aspace outside the medical tube, each of the secondary lumens being influid communication with the primary lumen via at least one respectiveopening in the at least one interior wall.
 18. The medical tube of claim17, each of the secondary lumens being in fluid communication with theprimary lumen via a plurality of openings spaced longitudinally along alength of the at least one interior wall.
 19. The medical tube of claim16, the primary lumen having a smaller cross-section in the distalregion than in the proximal region.
 20. An assembly comprising themedical tube of claim 16 and a clearance member received within theprimary lumen to clear debris therein.
 21. The assembly of claim 20, theclearance member being a wire-form clearance member.
 22. The assembly ofclaim 20, the clearance member being made of an elastic material suchthat it can adjust to an available cross-sectional area within theprimary lumen at a given location.
 23. The medical tube of claim 16, theprimary lumen having a generally round cross-section.
 24. The medicaltube of claim 23, wherein the secondary lumen are arrangedcircumferentially and forming arcuate channels spaced apart adjacent anouter circumference of the primary lumen, each of the secondary lumensbeing in fluid communication with the primary lumen via a plurality ofopenings spaced longitudinally along a length of the at least oneinterior wall.